Trials / Completed
CompletedNCT01342874
Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus
Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- G. d'Annunzio University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.
Detailed description
Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Inositol | inositol exposure in early GDM |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-04-01
- Completion
- 2011-08-01
- First posted
- 2011-04-27
- Last updated
- 2012-02-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01342874. Inclusion in this directory is not an endorsement.